ICH Q5A(R2) Draft Guideline Reaches Step 2

11 October 2022 — ICH announced the ICH Q5A(R2) draft guideline reached Step 2 of the ICH process.

The ICH Q5A(R2) draft Guideline on Viral Safety Evaluation of Biotechnology Products reached Step 2 of the ICH process on 29 September 2022. The R2 revision retains key principles of the original Guideline and provides additional recommendations on the established and complementary approaches to control the potential viral contamination of biotechnology products. A Step 2 Informational Presentation has been developed by the Q5A(R2) EWG to summarize the content of the draft Guideline.

Read more online 
Copyright Widler & Schiemann AG 2022. All Rights Reserved. /